Device For Collecting Fecal Discharge In Incontinent Patients

ABSTRACT

A collector for fecal discharge is provided comprising a self-expanding resilient collection component, a housing sheath and a transit component. The collection component has an open proximal and distal end and a lumen connecting them. The component comprises interconnected resilient arms circumscribing its contour, wherein adjacent arms are resiliently biased away from each other for exerting outwardly radial pressure for expanding and anchoring the component to rectal walls upon deployment. The housing sheath comprises a flexible and resilient material overlaying at least one of inner or outer contour of collection component without interfering with or blocking its ends or lumen. The transit component provides a conduit for fecal discharge to migrate from collection component to a receptacle and comprises a flexible, tubular sheath having a first open end connected to a second end by a lumen, wherein the first end engages with the proximal end of the collection component.

The present invention is related to a device for collecting fecaldischarge, and devices and methods for deployment thereof.

BACKGROUND

The present invention relates to solutions for containment or managementof fecal output. Options for containment or management of fecal outputknown in the art include absorbent pads in the form of diapers orsanitary napkins, anal plugs, fecal collectors in the form of collectionbags or pouches, and indwelling catheters.

Of the various available solutions, indwelling catheters provide apromising solution for managing fecal incontinence. An indwellingcatheter is placed inside the rectum and a retaining member comprising aresilient ring or an inflatable balloon or cuff is used to hold thecatheter inside the rectum. The retaining member is delivered in acompressed state into the rectum through the anal opening, and isallowed to, or caused to expand within the rectum. In its expandedstate, the retaining member abuts against the shelf provided by theanorectal junction (which provides a shelf at the junction between thebroader passage of the rectum and the narrower anal canal) and isprevented from being unintentionally withdrawn from the rectum andthrough the anal opening. The retaining member also provides an annularlumen to allow passage of stool. The retaining member is connected to acollection bag, for feces.

Existing indwelling catheters have several shortcomings.

A primary drawback of prior art devices is that the retaining member isconfigured to assume and retain its expanded state within the rectum,causing the resilient ring or inflatable structure to apply a continuousexternally directed radial force against the walls of the rectum,causing rectal tissue aggravation, mucosal damage, rectal stenosis,degeneration of the internal or external nerves and rupture of thesuperior rectal blood vessels.

Additionally, in the natural state, fecal matter is expelled from thecolon and rectum by a wave like muscular contraction of the colon andrectal walls (peristalsis) and a corresponding relaxation of thesphincter. Peristaltic contractions cause the rectal walls to expand andcontract to move fecal matter towards the anal opening. In cases where aprior art indwelling catheter has been inserted into the rectum,externally directed radial forces exerted by the retaining memberinterferes with peristaltic contractions at the point at which saidmember has been disposed within the rectum. The continual pressureexerted by the resilient member also causes damage to the rectal wallsand to the internal or external sphincter leading to permanentdysfunction.

In certain cases, the resistance presented by the resilient member tothe rectal walls during peristaltic contractions causes said resilientmember itself to be expelled towards the anal opening, until it isforced to abut against the anorectal junction, or in some cases isexpelled entirely from the anal canal.

Prior art devices additionally fail to taken into account physiology ofthe rectum and anal canal. The anorectal junction (the common boundaryof the rectum and anal canal) provides a limiting boundary forparticular nerve types. Visceral nerves are found above the anorectaljunction, while somatic nerves are found below said junction. Somaticnerves are capable of sensing pain, while visceral nerves only sensepressure and not pain. By virtue of the somatic nerves, the anorectaljunction and portions below it are extremely sensitive, and cause a highlevel of discomfort in case of foreign objects located within the analcanal.

A large number of prior art devices rely on a retaining member locatedat and abutting against the shelf provided by the anorectal junction. Inother prior art devices, as a consequence of resistance of the retainingmember to peristaltic contractions, said devices are moved as aconsequence of the peristaltic contractions toward the anal opening,until they rest against the shelf provided by the anorectal junction. Asa result of the retaining member residing at the anorectal junction, thepatient is constantly aware of a foreign body sensation with resultingdiscomfort. For this reason, prior art devices have not beenparticularly successful for patients, other than those in intensivecare.

In terms of effectiveness, prior art devices have so far only beensuccessful with respect to non-solid fecal matter. Limitations toeffectiveness have multiple causes. First, the anal canal and anorectaljunction provide passages with a limited lumen diameter for passage offecal matter. Situating a retaining member comprising either acontinuous ring (or cylinder) of resilient material, or an inflated cuffor balloon, within the rectum further reduces the lumen diameter to asignificant extent, which reduces the available volume for passage offecal matter. The reduction in available lumen diameter precludes thepassage of any significant quantity of solid fecal waste.

Another constraint faced by prior art devices is the likelihood of beingdislodged. Regardless of whether the retaining member comprises aresilient ring or an inflatable cuff, the upper rim of such resilientring or cuff (the rim which is furthest from the anal opening) presentsan abutment surface against which descending fecal waste wouldnecessarily impact. Pressure exerted by descending solid fecal wasteagainst the abutment surface causes the retaining member to bedislodged, so that it no longer presents the complete annular lumen forpassage of stool, consequently causing leakage or seepage along outsidewalls of the resilient member. Moreover, once dislodged, the resilientmember presents an increased abutment surface area, against whichpressure continues to be exerted by solid fecal waste, eventuallyleading to the entire device being expelled from the anal opening.

Owing to the limitations in addressing solid fecal discharge, usefulnessof prior art devices is limited to addressing liquid fecal discharge,which is typically observed only in patients in intensive care.

Prior art devices also face a serious drawback in terms ofleakage/seepage caused by peristaltic contractions. FIGS. 16 to 17Aillustrate cross sectional plan views of the retaining member of priorart devices and the consequences of peristaltic contractions by therectal walls. The teachings of said figures are equally applicable tocases where the retaining member is a resilient ring, and where theretaining member is an inflatable cuff. In both cases, the retainingmember presents a solid, continuous annular surface that resides againstthe rectal walls.

In FIG. 16 a retaining member 10 of the kind observed in prior artdevices is in its fully expanded state, and assumes a uniformly circular(or substantially circular) shape. FIG. 16A demonstrates the effect ofinwardly directed radial forces F along certain points on thecircumference of said retaining member 10, in that portions of theresilient member on which inward forces F are directed, deform inwards,while other portions are correspondingly deformed outwards.Corresponding outward deformation of portions of retaining member 10 isa consequence of the solid and continuous annular structure of saidretaining member 10. Where retaining member 10 is a resilient ring, theoutward deformation is a consequence of the resilient properties of theconstituting material. Where the retaining member 10 is an inflated cuffor balloon, the outward deformation is a consequence of relativeincompressibility of air within the cuff or balloon, which appliescorresponding pressure on other portions of the resilient member.

FIG. 17 illustrates retaining member 10 in its fully expanded state whendisposed within the rectum. Adjacent rectal walls 94 are illustrated ina relaxed state, wherein no inwardly directed forces are applied onretaining member 10. In FIG. 17A the rectal walls 94 are illustratedundergoing a peristaltic contraction, wherein inwardly directed radialforces F are applied at various points on the circumference of retainingmember 10. Since the inwardly directed compressive forces F are appliedacross the circumference of retaining member 10, said member 10 isforced to collapse inwardly into a series of substantially U-shapeddeformations, with a view to reduce the circumferential surface areapresented by retaining member 10 adjacent to rectal walls 94. TheU-shaped deformations interfere with and reduce available lumen volumefor passage of fecal matter through the retaining member.Simultaneously, such U-shaped deformations created gaps between rectalwall 94 and circumference of retaining member 10, through which fecalmatter can pass, leading to seepage or leakage along the outside of thedevice.

In addition to the disadvantages set out above, it has generally beenobserved that prior art devices require a trained care provider toprescribe, insert, maintain and remove the device.

The applicant has recognized a need for a collection device for fecaldischarge that addresses all of the above shortcomings, embodimentswhereof are described herein.

SUMMARY OF THE INVENTION

The present invention is directed to a device that addresses theshortcomings in the prior art. A collector for fecal discharge havingthe features of the present invention comprises a self-expandingresilient collection component, a housing sheath and a transitcomponent.

The collection component has an open proximal end, an open distal endand a lumen along the longitudinal axis of said component. The lumenprovides a passage connecting the open proximal and distal ends. Thecollection component is constructed from a plurality of interconnectedresilient arms that define spaces between the arms. The armscircumscribe the contour of the collection component. Adjacent armswithin the collection component are resiliently biased away from eachother so as to exert outwardly directed radial pressure. The outwardlydirected radial pressure serves to expand the collection component andanchor it to rectal walls upon deployment within the rectum. Thecollection component is configured to exert radial pressure less thanthe pressure exerted by the adjacent rectal walls during peristalticcontractions.

The housing sheath has a flexible and resilient material overlaying oneor both of the inner and outer contours of the collection component,without interfering with or blocking the open proximal and distal endsof said component and without interfering with or blocking the lumenconnecting the open ends.

The transit component is a flexible substantially tubular sheath thatprovides a conduit for fecal discharge to migrate from the collectioncomponent to a receptacle. The transit component has a first open end, asecond end, and a lumen connecting the two ends. The first open end ofthe transit component engages with the proximal end of the collectioncomponent.

The arms of the collection component may be pliant along the x, y and zaxes. In accordance with a specific aspect of the invention, the arms ofthe collection component may have shape memory.

The arms of the collection component may circumscribe any one of acircular, substantially circular, cylindrical, substantiallycylindrical, hemi-spherical, conical, frusto-conical, cup-shaped orfunnel-shaped contour for the collection component.

In accordance with a particular aspect, the interconnected arms may forman undulating series of paired arms. Each pair of arms may be coupled tothe two laterally adjacent pairs, and the first and last paired sets ofarms may be coupled to each other to complete the contour of thecollection component.

The interconnected arms may comprise a single continuous strand ofresilient wire material arranged to circumscribe the contour of thecollection component in an undulating configuration. In this aspect thefree ends of said wire material are joined to complete said contour. Inaccordance with a particular aspect, said continuous strand of resilientwire material may be arranged in one or more torsion loops on one ormore of the vertices formed by the peaks and troughs of the undulatingwire material.

In another aspect of the invention, the interconnected arms of thecollection component may be discrete, wherein adjacent arms are coupledto each other by connectors. In an more particular aspect adjacent armsof the collection component are coupled with resilient connectors thatbias the coupled arms away from each other.

In an embodiment of the invention, arms of the collection component maybe arranged in a series of crossed arm pairs arranged to circumscribethe contour of the collection component. The crossed arms within eachpair are coupled at their respective longitudinal midpoints by a pivotpin. Free top and bottom ends of each crossed arm pair are coupledrespectively to the adjacent free top and bottom ends of the laterallyadjacent crossed arm pairs by pivot pins. The free top and bottom endsof the first crossed arm pair and free top and bottom end of the lastcrossed arm pair are coupled to each other to complete said contour.

The arrangement of arms circumscribing the contour of the collectioncomponent may be configured as a plurality of annular elements. Theannular elements of the collection component have substantiallyidentical contours and are coaxially aligned along the longitudinal axisof the collection component. Each annular element may be coupled to atleast one adjacent element to achieve the contour of the collectioncomponent. In an embodiment, the elements are not coupled to each other,and are instead retained in longitudinal alignment relative to eachother, by the housing sheath.

In another embodiment, the contour of the collection component may befrusto-conical, with the outer sidewall connecting the proximal end anddistal end of the collection component at an outwardly directed angle ofbetween 10° and 30° from the normal. The collection component may havefasteners to adhere to the rectal walls.

In an aspect of the invention, the expanded collection component mayhave an external diameter of between 20 mm and 60 mm. In another aspect,in its collapsed state, the collection component may have an externaldiameter of between 6 mm and 21 mm. In a further aspect the expandedcollection component may have an internal diameter of between 20 mm and40 mm at the open proximal end, and an internal diameter of between 20mm and 60 mm at the open distal end. Yet more particularly, the expandedcollection component may have an internal diameter of between 33 mm and35 mm at the open proximal end, and an internal diameter of between 53mm and 55 mm at the open distal end.

In an embodiment, length of the collection component may be between 10mm and 50 mm.

In a specific embodiment of the invention, the outwardly directed radialpressure exerted by the collection component may be between 1 to 106 cmof H₂O. In a more specific embodiment, the outwardly directed radialpressure exerted by the collection component may be between 1 to 48 cmof H₂O. In another embodiment the outwardly directed radial pressureexerted by the collection component may be between 10 to 30 cm of H₂O,and in another embodiment may be 27.19 cm of H₂O.

The collection component may have one or more filaments attachedthereto. Free ends of the one or more filaments are arranged to trailthe proximal end of the collection component. In an embodiment, freeends of the one or more filaments may be arranged to have differingdegrees of slack.

In a particular embodiment, the one or more filaments may be woventhrough the collection component in a drawstring arrangement. In a morespecific embodiment, the filaments may be woven through vertices of theinterconnected arms, which vertices are situated on one or both of theproximal end and distal end of the collection component.

Each trailing end of the filaments is housed within a correspondingrigid or semi-rigid longitudinal conduit and thereafter connected to ahandle. Each conduit permits free movement of the residing filamentalong the direction of the conduit's longitudinal axis. One end of eachconduit is located adjacent the proximal end of the collectioncomponent.

In an embodiment, the profile of the housing sheath corresponds with theprofile of the collection component. In another embodiment, the materialfor the housing sheath is a polymeric material.

The second end of the transit component may be an open end having aconnector thereon. The connector engages with the receptacle for fecaldischarge. The second end of the transit component may alternatively beclosed, which closed end serves as the receptacle for fecal discharge.In an embodiment the material for the flexible and resilient tubularsheath of the transit component is a polymeric material.

These and other embodiments, features and advantages will becomeapparent to a person of skill in the art when read in connection withthe detailed description and accompanying drawings.

DESCRIPTION OF THE ACCOMPANYING DRAWINGS

FIG. 1 shows a collection component in an expanded state.

FIG. 1A shows the collection component in a compressed state.

FIG. 1B shows the collection component in an expanded state withcorresponding x, y and z axes superimposed thereon.

FIG. 1C shows compression of the collection component in response toinwardly directed radial forces directed along the x and y axes.

FIG. 1D shows the collection component in an expanded state withcorresponding x, and z axes superimposed thereon.

FIG. 1E shows compression of the collection component in response tolongitudinally directed force along the z axis.

FIG. 2 shows the collection component in an expanded state, having afilament or thread woven through its vertices with trailing ends.

FIG. 2A shows the collection component in a compressed state, whereininwardly directed radial forces for compression are generated by axialforce applied to the trailing ends of the filament or thread in adirection distal to said component, and simultaneous abutment of thevertices of the component against an unyielding surface.

FIG. 3 shows the expanded collection component of FIG. 2 wherein thetrailing ends of the filament or thread are passed through piping orchannels and thereafter connected to a handle.

FIG. 3A shows the compressed collection component of FIG. 2A whereindistal axial force applied to the trailing ends of the filament orthread is generated by pulling on the handle, and the unyielding surfaceagainst which vertices of said component abut is provided by the ends ofthe piping or channels proximal to said component.

FIGS. 4, 4A and 4B show the coiled or looped arrangement of the wireused to resiliently connect arms of the collection component.

FIGS. 4C to 4L show other arrangements for resiliently connecting armsof the collection component.

FIG. 5 shows an assembled internal component having the collectioncomponent housed within a sheath, and a transit component affixed to anend of the sheath.

FIG. 5A shows the assembled internal component of FIG. 5, the collectioncomponent having a filament or thread woven through its vertices,wherein the trailing ends of said filament or thread pass through pipingor channels, said piping or channels being housed within the transitcomponent.

FIG. 5B shows, the assembled internal component of FIG. 5A whereintrailing ends of said filament or thread are affixed to a connector andhandle.

FIG. 5C shows the assembled internal component of FIG. 5B wherein thecollection component is compressed by application of a distally directedaxial force applied to the trailing ends of the filament or thread bypulling on the handle, and simultaneous abutment of the bottom verticesof the collection component against the unyielding ends of the piping orchannels proximal to said collection component.

FIG. 6 shows a plunger for an insertion device.

FIG. 6A shows the plunger of FIG. 6 housed within the internal axialconduit of the assembled internal component of FIG. 5C.

FIG. 6B shows a cross-section of the plunger of FIG. 6 housed within theinternal axial conduit of the assembled internal component of FIG. 5C.

FIG. 7 shows the plunger of FIG. 6 having an insertion sleeve deployedthereon.

FIG. 8 shows the insertion device in a fully assembled state, whereinthe collection component and at least a part of the transit componentare housed within the plunger and insertion sleeve assembly of FIG. 7.

FIG. 9 shows an alternate embodiment of the plunger for the insertiondevice.

FIG. 10 shows the plunger of FIG. 9 having an alternate embodiment ofthe insertion sleeve deployed thereon.

FIG. 11 shows an alternate embodiment of the insertion device in a fullyassembled state, wherein the collection component and at least a part ofthe transit component are housed within the plunger and insertion sleeveassembly of FIG. 10.

FIG. 12 shows a first embodiment of the insertion sleeve.

FIG. 13 shows an alternate embodiment of the insertion sleeve havingselectively weakened wall portions.

FIG. 13A shows the embodiment of the insertion sleeve of FIG. 13,wherein said sleeve has been separated into two segments by applicationof opposing forces along the weakened wall portions.

FIG. 14 shows the fully assembled insertion device of FIG. 8 ready fordeployment in the rectum.

FIG. 14A shows the insertion device of FIG. 8 inserted into the rectumupto a predetermined depth or location.

FIG. 14B shows deployment of the assembled internal component byapplication of an axially directed force on the plunger of FIG. 8 in adirection towards the collection component.

FIG. 14C shows the assembled internal component deployed in a desiredlocation within the rectum, with the plunger and insertion sleeve ofFIG. 8 having been withdrawn.

FIG. 15 shows the fully assembled insertion device of FIG. 11 ready fordeployment in the rectum.

FIG. 15A shows the insertion device of FIG. 11 inserted into the rectumupto a predetermined depth or location.

FIG. 15B shows the insertion device of FIG. 11 after insertion into therectum, wherein a locking mechanism is disengaged, and withdrawal of theinsertion sleeve is commenced.

FIG. 15C shows the deployment of the collection component by withdrawalof the insertion sleeve of FIG. 11, in a direction away from thecollection component.

FIG. 15D shows the collection component and transit tube deployed in adesired location within the rectum, with the plunger and insertionsleeve of FIG. 11 having been withdrawn.

FIG. 16 shows a plan view cross-section of a retaining member of a priorart indwelling catheter in its fully expanded state.

FIG. 16A shows a plan view cross-section of a retaining member of aprior art indwelling catheter when inwardly directed radial forces areapplied at specific points on its circumference.

FIG. 17 shows a plan view cross-section of a retaining member of a priorart indwelling catheter in its fully expanded state when disposed withinthe rectum.

FIG. 17A shows a plan view cross-section of a retaining member of theprior art indwelling catheter when disposed within the rectum while therectum undergoes a peristaltic contraction.

FIG. 18 shows the internal physiology of the rectum.

DETAILED DESCRIPTION OF THE INVENTION

The detailed description of the invention may be read with reference tothe accompanying drawings. The drawings, which are not necessarily toscale, depict certain embodiments and are not intended to limit scope ofthe invention. The detailed description illustrates the invention byexample, and not by limitation. The written description and drawingswould enable the skilled person to make and use the invention.

The invention provides a collector of fecal discharge, for deploymentwithin the rectum, said device comprising a collection component, asheath for said collection device, a transit component and optionally, aseparate receptacle, said collector configured to be deployed in therectum. The collector additionally has a withdrawal mechanism forremoval from the rectum. The invention further provides a system andapparatus for deployment of the collector of fecal discharge. Theinvention also addresses methods for deployment and withdrawal of saidcollector.

The collection component of the invention is a pliant self-expandingstructure that adheres to the wall of the rectum with complianceselected to ensure that it anchors to the rectal walls and collapses andexpands corresponding to movement of the adjacent anatomy duringperistaltic contractions.

FIGS. 1 to 4L show specific embodiments of the collection component.

FIGS. 1 and 1A depict an embodiment of self-expanding collectioncomponent 1 in its expanded and compressed states respectively.

The desired self-expanding and pliant properties of collection component1 may be achieved by constructing said component using one or more ofshape memory alloys, spring steel, stainless steel, thermoplasticpolymers, and natural or synthetic material having elastic or resilientproperties. Additionally, pliancy and resilience may be achieved byconnectors—resilient and non-resilient—between various elements of thecollection component 1, embodiments whereof are described herein.

In FIGS. 1 and 1A, collection component 1 is constructed from wirematerial 11 having shape memory. Collection component 1 in shown in anorientation where, upon deployment within the rectum, upper plane 16(the “distal end”) is situated distal to the anal opening, and lowerplane 17 (the “proximal end”) is situated proximal to the anal opening.For the purposes of this written description, reference to proximal anddistal ends of various elements of collection component 1 are assumed tocorrespond to this orientation.

Collection component 1 may have any one of a circular or substantiallycircular, cylindrical or substantially cylindrical, hemi-spherical,conical, frusto-conical, cup-shaped or funnel-shaped contour, or suchother contour as may be selected to correspond to the shape of therectum. It would be understood by the skilled person that shape andconfiguration of collection component 1 may be selected so as to exertminimal and evenly distributed radial pressure on the adjacent rectalanatomy, with a view to minimize patient discomfort and to avoid risksof rectal necrosis. Shape and configuration of said component 1 isadditionally selected with a view to ensure that component 1 does notsuffer inelastic deformation or inelastic collapse.

Collection component 1 is constructed from an arrangement of arms 11Acircumscribing (and accordingly defining the structural member having)the desired contour. The configuration of arms 11A along the contour ofcollection component 1 defines spaces (“interspaces”) between adjacentarms 11A. Arrangement of arms 11A to circumscribe the desired contour ofcollection component 1 defines an open proximal end and an open distalend, and a lumen passing through said collection component 1 along thelongitudinal axis and connecting said open proximal and distal ends.Upon application of inwardly directed radial forces upon collectioncomponent 1, arms 11A are forced closer to each other, thereby reducingthe interspaces defined therebetween, and reducing the circumference andtotal surface area of the outside contour of collection component 1. Theinterspaces defined by the arrangement of arms 11A accordingly ensuresthat any part (or the whole) of collection component 1 may be compressedinwardly without effecting adjacent portions of said component 1, andwithout giving rise to u-shaped deformations that would serve to occludethe lumen of collection component 1. Further, the arrangement allows forinward compression of the whole or portions of collection component 1without forcing portions of the outer contour of collection component 1to separate from the adjacent anatomy.

The arm 11A—interspace arrangement of collection component 1 accordinglyaddresses two critical shortcomings of prior art devices whereinperistaltic contractions would cause the lumen of an indwellingcomponent to be occluded by u-shaped deformations, while simultaneouslygiving rise to leakage of fecal discharge through gaps arising betweenthe outer circumference of said indwelling component and adjacent rectalwalls.

In FIGS. 1 and 1A, the arms 11A are arranged at a slant relative to thelongitudinal axis of collection component 1 and are interconnected toform an undulating series of paired arms. Arms 11A within any pair maybe connected to each other at one of the proximal or distal end therebycreating a vertex-like shape. In the embodiment shown, arms 11A withineach pair are connected at the same end as in the remaining pairs.Further, each pair of arms is connected to the two laterally adjacentpairs of arms, to form a series of undulations. Depending on thepreferred structure for the collection component 1, the undulations maybe sinusoidal, zig-zag or an irregular series of alternating peaks andtroughs. Paired arms are added to the structure and arranged tocircumscribe the desired contour of collection component 1, wherein thesingle free end of the first paired set of arms and the single free endof the last paired set of arms are connected to complete the structureof the collection component 1.

The slant of arms 11A relative to the longitudinal axis of collectioncomponent 1 and the undulating structure of collection component 1defines the interspaces between each arm 11A to allow for compressionand expansion. The configuration, shape memory and resilient propertiesof the material selected for arms 11A and interconnections therebetweendetermine the pliancy, resilience, radial strength and self-expandingproperties of collection component 1.

Arms 11A of collection component 1 may be independently pliant andresilient along all three axes. FIGS. 1B and 1C show collectioncomponent 1 in a fully expanded state and in a compressed staterespectively, wherein in FIG. 1C inwardly directed radial forces Fcauses arms 11A and said collection component 1 to compress along the xand y axes. FIGS. 1D and 1E show collection component 1 in a fullyexpanded state and in a compressed state respectively, wherein in FIG.1E inwardly longitudinally directed force F′ causes arms 11A ofcollection component 1 to compress along the z axes. Upon termination offorces F or F′, the resilient and shape memory properties of said arms11A and connectors therebetween causes said arms 11A and said collectioncomponent 1 to revert to the expanded shape of FIGS. 1B or 1D. It wouldbe understood that while FIGS. 1B to 1D show compressive forces appliedalong a maximum of any two axes of collection component 1, said forcesmay be applied simultaneously along all three axes, and the individualarms 11A and collection component 1 would still compress and expand inthe manner illustrated.

The compressive and expansive properties of collection component 1 andits structural arms 11A in response to inwardly directed radial forces Falong the x and y axes allows said component 1 to expand and contract inresponse to expansions and contractions of adjacent rectal walls,thereby ensuring that collection component 1 adheres to rectal walls.

The compressive and expansive properties of collection component 1 inresponse to inwardly directed longitudinally forces F′ allows saidcomponent 1 to expand and contract in response to pressure exerted byfolds of tissue and wrinkles on the inner surface of the rectal walls,against which portions of collection component 1 (particularly vertexportions thereof) abut, without allowing such movement to dislodgecomponent 1 from its position relative to the rectum.

FIG. 18 illustrate certain portions of the rectum 93. Typically, uponinsertion in the rectum, some or all parts of proximal or distal ends ofcollection component 1 may abut against folds of tissue and/or wrinklesfound on the inner surface of the rectal walls 94. In certain cases,such abutment may be against the first transverse fold 95 or the secondtransverse fold 97 of the rectum. Peristaltic contractions, or othermuscular movement may cause said folds or wrinkles to bear against thecollection component 1, thereby applying inwardly directed longitudinalforce against component 1, in response to which said component 1 wouldcompress along its longitudinal axis, without being dislodged relativeto the rectum. Upon termination of application of said force, collectioncomponent 1 resumes its original shape as a consequence of the resilientand shape memory properties of its arms 11A.

It would be understood that the configuration of collection container 1as described above can be achieved in a number of different ways. In theembodiment shown in FIGS. 1 and 1A, configuration of collectioncomponent 1, arms 11A and interconnection between said arms 11A isachieved by arranging a continuous strand of wire material 11 havingshape memory characteristics in an undulating configuration, and joiningthe ends of said wire material 11 to impart a substantially cylindricalor frusto-conical contour to the wire arrangement. At one or more of thevertices of the undulating wire arrangement, wire material 11 may beconfigured to have at least one loop or coil 12, which loop or coil 12acts as a torsion spring to provide additional shape memory and pliancyto collection component 1.

Front, side and perspective views of a single loop coil arrangement areprovided in FIGS. 4, 4A and 4B respectively. While the embodimentsillustrated in FIGS. 4, 4A and 4B show only a single loop or coil ateach vertex, a plurality of loops or coils could be provided—the numberof loops or coils at each vertex 12 being selected based on the desiredtorsional resilience.

Collection component 1 may also be constructed without any loops orcoils 12, and may rely entirely on shape memory and elastic propertiesof the underlying material of arms 11A for the desired resilience andpliancy to ensure that in its expanded state, said component 1 adheresto adjacent rectal walls. In an embodiment, some or all parts ofcollection component 1 may have a polymeric material coated or otherwiseaffixed thereon for improved cushioning and adherence.

In a preferred embodiment, 0.3 to 2.0 mm medical grade stainless steelwire is used for constructing the arms 11A of collection component 1,which provides significant radial strength and was found to improveadherence of said component 1 to the rectal walls, while minimizing thelikelihood of injury, trauma or involuntary migration of said component1. In a particularly preferred embodiment 0.7 mm medical grade stainlesssteel wire may be used for constructing said arms 11A. In a yet morepreferred embodiment said wire material is medical grade 316 stainlesssteel wire.

The ends of the underlying material for arms 11A may be joined to eachother using a variety of methods that would be immediately apparent to aperson of skill in the art. In a preferred embodiment, butt joints orlap joints may be used.

In another embodiment, arms 11A of collection component 1 are discretearms having shape memory characteristics and connected to each other byconnectors, in an undulating configuration.

Arms 11A may be connected to circumscribe any one of a circular orsubstantially circular, cylindrical or substantially cylindrical,hemi-spherical, conical, frusto-conical, cup-shaped or funnel-shapedcontour, or such other contour as may be appropriate to conform to shapeof the rectal walls.

Connectors used to connect the discrete arms 11A may comprise any one ofa variety of mechanisms that would be immediately apparent to a personof skill in the art, with a view to ensuring pliancy and resilience ofcollection component 1. Embodiments of various connectors and areillustrated in FIGS. 4C to 4J.

FIGS. 4C and 4D show front and perspective views of an embodiment whereadjacent arms 11A are connected with a C-shaped loop 12A, wherein loop12A and two adjacent arms 11A may be formed from a single material as acontinuous piece, or alternately from a plurality of elements joinedtogether, wherein said plurality of elements may be manufactured usingthe same underlying material or different materials. The material forC-shaped loop 12A may be selected based on the desired shape memory,resilience, radial strength and pliancy.

FIGS. 4E and 4F show front and perspective views of an embodiment whereadjacent arms 11A are connected at the vertex with a substantiallyu-shaped or substantially v-shaped connection 12B. Connection 12B andtwo adjacent arms 11A may be formed from a single material as acontinuous piece, or alternately from a plurality of elements joinedtogether, wherein said elements may be manufactured using the sameunderlying material or different materials. The material for theconnection 12B may be selected based on the desired shape memory,resilience, radial strength and pliancy.

FIGS. 4G to 4J show embodiments where adjacent arms 11A are connectedwith a cylindrical pin or pivot pin arrangement 12C, and a resilientconnector 12D, 12E interposed between the two arms 11A. The resilientconnector serves to push arms 11A apart from each other, causingcollection component 1 to have self-expanding characteristics.

FIGS. 4G and 4H show a front view and a perspective view of anembodiment wherein resilient connector 12D comprises arms having ac-shaped loop wherein each arm of said connector 12D is connected to oneof the two adjacent arms 11A.

FIGS. 4I and 4J show front and perspective views of an embodimentwherein resilient connector 12E comprises a compression spring, each endof said spring 12E connected to one of adjacent arms 11A.

It would be understood that in addition to the specific embodiments ofresilient connector 12D, 12E discussed herein, any other object withshape memory or resilient properties may be used to cause adjacent arms11A to move apart from each other, thereby causing collection component1 to expand.

FIGS. 4K and 4L show a configuration for a particular embodiment ofcollection component 1 wherein arms 11A′ are connected to each other ina collapsible scissor arrangement.

In FIG. 4K, arms 11A′ are arranged in a series of crossed pairs, whereincrossed arms 11A′ within each pair are connected at their respectivelongitudinal midpoints (or substantially their longitudinal midpoints)using connectors that permit rotational movement. In a preferredembodiment said connectors comprise cylindrical pins or pivot pins 12G.The free top and bottom ends of crossed arms 11A′ on each side of acrossed pair is connected respectively to the adjacent free top andbottom ends of crossed arms 11A′ of the next crossed pair. Said free topand bottom ends are connected to each other using connectors that permitrotational movement. In a preferred embodiment said connectors comprisecylindrical pins or pivot pins 12C′.

Crossed pairs of arms 11A′ are added to the structure and arranged tocircumscribe the desired contour of the collection component 1, whereina free top and bottom end of the first crossed pair of arms 11A′ and thefree top and bottom end of the last crossed pair of arms 11A′ areconnected to complete the structure of the collection component 1.

The arrangement of crossed pairs of arms 11A′ creates a network ofcrossed arms with diamond shaped and triangular interspaces definedtherebetween. Said arrangement creates a collapsible scissorconfiguration, which allows for compression and expansion of collectioncomponent 1. The configuration, shape memory and resilient properties ofthe material selected for the arms 11A′ determines the pliancy,resilience and self-expanding properties of collection component 1.

FIGS. 4K and 4L show a section of the collapsible scissor arrangement inan expanded and collapsed state respectively. In a preferred embodiment,the interconnected top and bottom ends of each set of adjacently placedcrossed pairs of arms 11A′ are connected to each other by a resilientconnector. In a preferred embodiment resilient connector 12F is atension spring or an extension spring. As shown in FIG. 4L, applicationof inwardly directed radial forces causes adjacent crossed pairs of armsto move closer to each other in a lateral direction, correspondinglymoving the top and bottom ends of said crossed pairs away from eachother. The increase in distance between the top and bottom ends placesan axial load upon resilient connector 12F. Upon termination ofapplication of inwardly directed radial compression, resilient connector12F resumes its relaxed position, thereby bringing the top and bottomends of adjacent crossed pairs of arms 11A′ closer to each other, andcorrespondingly increasing the interspaces defined between adjacentcrossed pairs. Said movement causes collection component 1 to movetowards and attain its expanded state.

As in the earlier embodiment, interspaces defined between arms 11A′ ofcollection component 1 allows said arms to move closer to each otherupon application of inwardly directed radial forces. Said movementreduces the circumference and total surface area of the outside contourof collection component 1. The reduction in circumference ensures thatany part (or the whole) of collection component 1 may be compressedinwardly without effecting adjacent portions of said component 1, andwithout giving rise to u-shaped deformations that would serve to occludethe lumen of collection component 1. This additionally avoids thecorresponding formation of spaces between the outer contour ofcollection component 1 and the adjacent rectal walls, and the consequentproblem of leakage.

In an embodiment of the invention, the arrangement of armscircumscribing the contour of collection component 1 may be configuredas a plurality of annular elements each having a cylindrical,substantially cylindrical or frusto-conical contour. The contours ofsaid plurality of annular elements are substantially identical, and saidelements are aligned along the longitudinal axis of the collectioncomponent. Each annular element may be resiliently or otherwise coupledto the immediately adjacent annular element to achieve the desired sizeand contour of collection component 1. It would be understood that eachannular element may be configured in any of the arm—interspacearrangements disclosed in connection with the collection component as awhole. In another embodiment, annular elements are not coupled to eachother, and are instead retained in longitudinal alignment relative toeach other, by the housing sheath.

It would be understood that in addition to the specific embodiments andconfigurations for the arms, connectors and resilient connectorsdiscussed herein, any other elements or components with the desiredshape memory or resilient properties may be used to cause collectioncomponent 1 to expand and contract in an efficient manner. Othermechanisms that may be used to impart self-expanding properties includedhydraulically actuated mechanisms, pneumatically actuated mechanisms andmagnetically actuated mechanisms.

Collection component 1 relies on its pliant and self-expandingproperties to ensure that its outer circumference adheres to adjacentrectal walls, thereby anchoring said collection component 1 to saidrectal walls when the rectum is relaxed, and also during peristalticcontractions. The circular, substantially circular, cylindrical,substantially cylindrical, hemi-spherical, conical, frusto-conical,cup-shaped or funnel-shaped contour, allows the outer contour ofcollection component 1 to correspond better to the adjacent anatomy ofthe rectum. Moreover, the increased surface area provided by theselected configurations in comparison to a ring like retainer device,ensures better anchoring properties.

Simultaneously, providing for interspaces defined between thearrangement of structural arms 11A, 11A′ of collection component 1allows for contraction of said component 1 without occlusion of thelumen therethrough and without separating the outer contour fromadjacent rectal walls.

In addition to the above, the independent pliancy of each arm 11A, 11A′and of collection component 1 as a whole along all three axes ensuresthat the incontinence device does not interfere with peristalticcontractions, and with the corresponding effectiveness of the fecaldischarge process. Additionally, the ability of the collection componentto expand and collapse corresponding to movement of the adjacent anatomyprevents the peristaltic contractions of the rectal walls and tissuefolds from dislodging the collection component from the desired locationand forcibly expelling it towards the anal opening.

Another advantage of having a collection component that expands andcollapses corresponding to movement of the adjacent anatomy is avoidanceof continual outwardly directed radial force on rectal tissue, thatcould eventually cause one or more of rectal tissue aggravation, mucosaldamage, rectal stenosis, degeneration of the internal or externalnerves, rupture of the superior rectal blood vessels, and damage to theinternal or external sphincter leading to permanent dysfunctioning ofthe sphincter. The compliant collection component 1 additionallysignificantly reduces foreign body sensation and patient discomfort.

In a preferred embodiment, collection component 1 has a frusto-conicalcontour, wherein the outer sidewall connecting the proximal end anddistal end is at an outwardly directed angle of between 10° and 30° fromnormal. Said configuration provides an optimal shape for collectioncomponent 1 to adhere to the rectal walls at the desired location,eliminates the risk of involuntary inward migration, and contributes totrauma free withdrawal. In a particular embodiment, collection component1 may have fasteners to assist in adhering to the anatomy of the rectum,including inter alia adhesives, hooks, clips, catches and clasps.

In the expanded state of an embodiment, collection component 1 may havean external diameter of between 30 mm and 60 mm. The external diameterof said collection component in a fully collapsed embodiment may liebetween 6 mm to 21 mm.

In an embodiment, collection component 1 has a frusto-conicalconfiguration wherein internal diameter at the proximal end 17 isbetween 30 mm and 40 mm, and internal diameter at the distal end 16 isbetween 50 mm and 60 mm. In another embodiment, collection component 1has a frusto-conical configuration wherein internal diameter at theproximal end 17 is between 33 and 35 mm, and internal diameter at thedistal end 16 is between 53 mm and 55 mm.

It would be understood that the longitudinal dimension of collectioncomponent 1 may be selected based on patient physiology, desiredresilience and state of the rectal walls. However, in a preferredembodiment, collection component 1 measures between 2 cm to 5 cm inlength along the axial direction, which provides sufficient anchorageagainst the rectal walls, without causing said component 1 to abutagainst the anorectal junction 96.

Clinical studies have demonstrated that empty rectum pressure ofincontinent persons is between 0 to 14 cm of H₂O. The pressure range atwhich persons first feel a sensation of rectal filling is between 6 to48 cm of H₂O. The maximum tolerable pressure that a person is likely totolerate before feeling an irresistible and painful urge to allow fecaldischarge is 106 cm of H₂O.

Based on these studies, it has been discovered that the full range ofoutward radial pressure that may be exerted collection component 1 onadjacent rectal walls is between 1 to 106 cm of H₂O. In a preferredembodiment, outward radial pressure exerted by collection component 1 onthe adjacent rectal walls is between 1 to 48 cm of H₂O. In a morepreferred embodiment, outward radial pressure exerted by collectioncomponent 1 on the adjacent rectal walls is 27.19 cm of H₂O. Said radialpressures have been selected with a view to minimize patient discomfortand foreign body sensation, while allowing collection component 1 toanchor against the rectal walls and expand and contract in response toperistaltic contractions.

Collection component 1 may be annealed using optimized parametersresulting in optimal radial strength and device finish.

The invention presents a significant improvement over prior art devicesof the indwelling catheter type in that such prior art devices areeither deployed (or forced by peristaltic contractions) to abut againstthe shelf provided by the anorectal junction 96 (FIG. 18), whichabutment prevents the device from being expelled entirely from therectum. Owing to the somatic nerves in the area, devices abutting theanorectal junction 96 cause acute foreign body sensation and patientdiscomfort. Additionally, ensuring that such devices are retained withinthe rectum is dependent on sphincter tone of an individual—in caseswhere sphincter muscles of an individual are weak, the anorectaljunction 96 fails to provide a suitable abutment surface to maintainprior art devices in position, leading to involuntary ejection of thedevice from the rectum.

Collection component 1 of the present invention however, is capable ofanchoring to the rectal walls as a result of its configuration andpliancy. Said component 1 therefore does not rely on the shelf of theanorectal junction 96 to maintain its location relative to the rectum.As a result, collection component 1 can be deployed and retained higherwithin the rectum, and preferably above the anorectal junction 96 andbelow the first transverse fold 95 or second transverse fold 97therewithin. In an embodiment, collection component 1 may be deployedbelow the third transverse fold 98. Since nerves in this area arevisceral and not somatic, the patient is only aware of pressuresensations, and not pain sensations in connection with presence ofcollection component 1. Further since collection component 1 isconfigured to be compliant with contractions of the adjacent rectalanatomy, even the pressure sensation is largely absent, leading to asignificantly reduced foreign body sensation and higher patienttolerance for the device.

FIGS. 2 and 2A show an embodiment of collection component 1 having atleast one filament or thread 13 woven or passed through vertices on itsproximal end 17 and distal end 16, and having the free ends of saidfilament or thread 13 trailing said proximal end 17. In an embodimentthe filament or thread 13 may be woven around the collection componentin a drawstring arrangement, wherein simultaneously pulling on the freeends of the filament or thread causes distal end 16 and proximal end 17to contract, and for said component 1 to collapse. In the embodimentshown in FIGS. 2 and 2A, filament or thread 13 is woven to pass througheach vertex 12 of collection component 1 at least once. However, otherarrangements to ensure an appropriate drawstring configuration would beimmediately apparent to the skilled person.

FIG. 2 shows collection component 1 in its fully expanded state, havingno inwardly directed radial forces acting upon it, such as when therectal walls to which it adheres are in a relaxed state.

FIG. 2A shows collection component 1 in a collapsed state for withdrawalfrom the rectum through the anal canal, wherein the inward radial forcesrequired for compression are generated by applying an axial force to thetrailing ends of the filament or thread in the direction moving fromdistal end 16 to proximal end 17 of said component 1 (“proximaldirection”), and simultaneous abutment of vertices 12 located atproximal end 17 of said component 1 against an unyielding surface 9(which unyielding surface may be provided by a care provider's handgripping the proximal end 17). Abutment of proximal end vertices 12against unyielding surface 9 prevents premature movement of collectioncomponent 1 in the proximal direction, while axial force applied to thethread or filament 13 in the proximal direction causes distal 16 andproximal 17 ends of collection component 1 to contract and for saidcomponent 1 to eventually collapse completely.

In an embodiment, the configuration of collection component 1 and thedrawstring arrangement of thread or filament 13 are chosen to ensurethat collection component 1 collapses sequentially. In a particularembodiment, the collection component 1 and drawstring arrangement ofthread or filament 13 is configured so that the sequence of collapseensures closing of substantially 70% of distal end 17, followed bysubstantially 100% of proximal end 16, and in turn followed by collapseof the remaining substantially 30% of distal end 17. Sequential collapseserves to reduce possible trauma (tissue pinching) arising fromcollapse, and prevents accidental soiling when collection component 1 iswithdrawn. Sequential collapse of collection component 1 may be achievedby providing differing degrees of slack to each trailing end of threador filament 13. Upon application of proximally directed axial force totrailing ends of thread or filament 13, the portion of collectioncomponent 1 linked to the trailing end having less slack will collapsefirst, while the portion of said component 1 linked to the trailing endhaving more slack will collapse only after the additional slack iscompletely exhausted by the proximally directed axial force.

In FIGS. 3 and 3A trailing ends of filament or thread 13 are passedthrough rigid or semi-rigid pipes or conduits 14 and are thereafterconnected to handle 15. Pipes or conduits 14 are selected with aninternal diameter that permits free movement of filament or thread 13residing within. Other criteria for selecting shape, configuration andconstruction material for said pipes or conduits 14 include inter aliaminimizing foreign body sensation and sphincter dysfunction.

FIG. 3 shows collection component 1 in its expanded state. In FIG. 3A,collection component 1 is collapsed by applying to handle 15, an axialforce in the proximal direction, which axial force is transmittedthrough handle 15 to filament or thread 13. The rigid or semi-rigidpipes or conduits 14 are prevented from moving in a proximal directionby the hand simultaneously gripping them. Abutment of proximal endvertices 12 of collection component 1 against unyielding surface9—provided by the adjoining ends of the pipes or conduits 14—preventsmovement of said collection component 1 in the proximal direction, whiletension applied to thread or filament 13 causes distal 16 and proximal17 ends of said component 1 to contract, and eventually for thecomponent 1 to collapse completely.

In a preferred embodiment, the thread or filament 13 may provide avisual indication when collection component 1 has been completelycollapsed. In another embodiment, the thread or filament 13 and handle15 may be configured to provide audible or tactile feedback whencollection component 1 has been completely collapsed. The thread orfilament 13 and handle 15 may further be provided with a locking orratchet mechanism to prevent collection component 1 from resuming itsexpanded state, by preventing said thread or filament 13 from beingwithdrawn into conduits 14.

FIGS. 5 to 5C show embodiments of collection component 1 having a sheathand transit component 21 affixed thereto.

FIG. 5 shows an assembled internal component 2 comprising collectioncomponent 1 housed within a thin, skin or tissue friendly housing sheath22, and having a transit component 21 affixed to its proximal end.Collection component 1 housed within said housing sheath 22 adheresresiliently to the rectal walls. Distal end 16 of said collectioncomponent 1 provides an opening 25 to funnel fecal discharge into thelumen through said component 1 into and onwards through transitcomponent 21.

Housing sheath 22 for collection component 1 overlays at least one ofthe inner or outer contour of component 1, while maintaining the openproximal and distal ends of component 1 and patency of the lumenconnecting said open ends. Housing sheath 22 assists in hosting,cushioning, blunting impact of, adhering, sealing and tapering of saidcomponent 1. Housing sheath 22 may be constructed of any one or more ofa variety of materials chosen inter alia for bio-compatibility,effectiveness in minimizing foreign body sensation, reduction of tissueirritation and damage, pliancy and adherence with rectal walls,structural strength, flow, bonding, and leak-proof and seepage resistantproperties. In a particular embodiment housing sheath 22 may be apolymer sheath. In a preferred embodiment housing sheath 22 comprises asemi-crystalline polymer. The polymeric material may be cross-linked ornon cross-linked and may be chosen with an orientation that wouldimprove tear properties.

Housing sheath 22 may be configured such that its profile at distal end16 of collection component 1 corresponds substantially to the profile ofdistal end 16 of said collection component 1. In the embodiment ofcollection component 1 shown in FIGS. 1 and 1A, profile of housingsheath 22 may be configured to substantially correspond and adhere tothe undulating circumferential configuration of collection component 1at distal end 16. In the embodiment of collection component 1 shown inFIGS. 4K and 4L, the profile of housing sheath 22 may be configured tosubstantially correspond and adhere to the profile of distal end 16 ofthe scissor configuration.

In another embodiment of collection component 1 shown in FIGS. 4K and4L, the housing sheath 22 may consist of material with elasticproperties, which properties bias the collection component towards itsexpanded state in the same manner as resilient connector 12F.

The configuration of housing sheath 22 minimizes and reduces seepage offecal matter from the edges of collection component 1 both in itsexpanded and collapsed states and also reduces impacting of fecal matterin comparison to an arrangement where a sheath presents a circularcircumference at distal end 16. Said construction and configuration ofhousing sheath 22 also reduces the likelihood of involuntary forwardmigration, or accidental dislodgement of collection component 1 as aconsequence of stool impacting against a continuously circularcircumferential arrangement.

Other mechanisms that may be incorporated for reducing seepage of fecalmatter from the edges of collection component 1, and for improvingtransit of solid stool from collection component 1 through transitcomponent 21, include inter alia vacuum suctioning and grinding.

In an embodiment, housing sheath 22 is uncoated and without any surfaceadditives. In another embodiment, at least one of the outside and insidesurfaces of housing sheath 22 may be coated. Coatings for housing sheath22 may be selected from the group of hydrophilic, hydrophobic, frictionenhancing, friction reducing, antimicrobial, anesthetic andanti-inflammatory coatings. The outside and inside surfaces of housingsheath 22 may have the same or different coatings, single or multiplecoatings, and on single or multiple locations to enhance desiredbehavior and properties.

Transit component 21 also comprises a thin, skin friendly substantiallytubular sheath having at least one open end, and having a lumen passingtherethrough, connecting said at least one open end to the other end. Asin the case of housing sheath 22, use of a compressible sheath for thetransit component 21 residing in the rectum and anal canal allows theanal sphincter to function in a normal fashion, thereby reducing ornegating manifestation of anal sphincter dysfunction. Additionally, useof a thin sheath as transit component 21 allows said transit component21 to be compressed by contractions of the rectal walls, anal canal andanal opening, thereby preventing patient discomfort, tissue necrosis anddegeneration of muscle tone leading to sphincter dysfunction.

Selection of appropriate sheath material for transit component 21improves ‘patient-friendliness’ of the device by reducing the magnitudeof foreign body sensation and resulting discomfort that a patient mayexperience. Characteristics on which selection of said sheath materialfor transit component 21 is based include bio-compatibility,effectiveness in minimizing foreign body sensation, reduction of tissueirritation and damage, pliancy and adherence with the rectal walls,structural strength, flow, bonding, and leak-proof and seepage resistantproperties.

In a particular embodiment the sheath for transit component 21 may be apolymer sheath. In a preferred embodiment said sheath for transitcomponent 21 comprises a semi-crystalline polymer. The polymericmaterial may be cross-linked or non cross-linked and may be chosen withan orientation that would improve tear properties. In a preferredembodiment, characteristics for selection of the polymeric materialinclude inter alia the orientation of the semi-crystalline polymer, itsextrusion process, surface characteristics such as lubricity,antimicrobial, hydrophilic, and anesthetic properties, are selected toreduce patient discomfort and opportunities for accidents or unfavorableoutcomes, and also to enable a health care provider to care for thepatients in an efficient manner.

In an embodiment, transit component 21 is uncoated and without anysurface additives. In another embodiment, at least one of the outsideand inside surfaces of transit component 21 may be coated. Coatings forsaid transit component 21 may be selected from the group of hydrophilic,hydrophobic, friction enhancing, friction reducing, antimicrobial,anesthetic and anti-inflammatory coatings. The outside and insidesurfaces of said transit component 21 may have the same or differentcoatings, single or multiple coatings, and on single or multiplelocations to enhance desired behavior and properties. The coatings ontransit component 21 may be same or different from coatings on housingsheath 22.

The structure of transit component 21 may take different geometricalshapes, dimensions and configurations. Said transit component 21 mayhave natural or non-natural conduits, which house other components thatare relevant for withdrawal of collection component 1. Transit component21 may also have internal activation or trigger mechanisms to flush orevacuate contents.

The at least one open end 26 of transit component 21 is affixed tohousing sheath 22 at proximal end 17 of collection component 1, suchthat fecal discharge funneled into opening 25 of collection component 1in turn passes through transit component 21. In an embodiment the otherend 24 of said transit component is also open and provides an outlet forfecal discharge into a receptacle, container or compartment. In anotherembodiment, transit component 21 is closed at said other end 24 therebyproviding a tubular receptacle for fecal discharge.

FIG. 5A shows assembled internal component 2, comprising collectioncomponent 1 housed within housing sheath 22, having one end 26 oftransit component 21 affixed to its proximal end 17, and having afilament or thread 13 woven through its top and bottom vertices in adrawstring arrangement, wherein trailing ends of said filament or thread13 pass through piping or conduits 14, wherein said piping or conduits14 are housed within transit component 21.

FIG. 5B shows an embodiment of assembled internal component 2 whereintransit component 21 has a ring or connector 23 at end 24 that serves asan interface to a receptacle, containment device or compartment. Theembodiment additionally has handle 15 to which the trailing ends offilament or thread 13 are attached.

FIG. 5C illustrates voluntary collapse of collection component 1 inassembled internal component 2, by application of an axial force appliedto handle 15 in the proximal direction, the mechanism for which isexplained above.

In an embodiment of the invention, at least one of collection component1 and transit component 21 include odor neutralizers for discharges fromthe rectum, including by way of contact or passage of such dischargesthrough one or more odor neutralizing substances such as inter aliaammonia gas, ground coffee beans, camphor, lime quartz and charcoal.Odor neutralizing substances may be provided by way of coatings oninternal surfaces of housing sheath 22 or of transit component 21.

In an embodiment, assembled internal component 2 may be attached toappropriate valve arrangements and collection devices through theconnectors or interfaces illustrated.

FIGS. 6, 6A, 6B, 7, 8 and 12 show components for, and an embodiment of,a device for insertion of assembled internal component 2 into therectum.

FIG. 6 shows a plunger 3 for the insertion device. Plunger 3 comprises arigid or semi-rigid insertion rod 31 having a base 33 and a head 32.Base 33 provides a flat surface for application of pressure to advanceplunger 3 or for gripping to withdraw the plunger. In the embodimentshown, head 32 is cylindrical with an open end 35 proximal to base 33,and with a capped end 34 distal from base 33. Capped end 34 may have ablunt rounded tip to facilitate insertion through the anal opening intothe rectum without protruding, scratching, entangling or any othermanner of tissue or skin trauma. Open end 35 provides access to cavity36 within head 32. Cavity 36 may extend partially or substantiallythrough head 32.

Head 32 may be constructed from a variety of inert or biocompatiblematerials, including inter alia a soft, derma-tissue friendly material.Further, said head 32 may be shaped so as to facilitate smooth,non-traumatic insertion and removal. Head 32 may have one or morecoatings, a secondary substrate or substrates on its external surface,which improve lubricity while reducing tissue trauma and patientdiscomfort.

In a preferred embodiment, the cross-sectional profile of head 32 issmall, and selected with a view to reduce trauma and foreign bodysensation.

FIG. 6A and 6B show plunger 3 housed within the internal axial conduitof assembled internal component 2. Head 32 of plunger 3 protrudes fromopening 25 of assembled internal component 2. Base 33 protrudes fromopening 24 of said assembled internal component 2. Insertion rod 31 ishoused within or substantially within the axial conduit of saidassembled internal component 2.

Owing to the pliant characteristics of collection component 1 and thematerial characteristics of transit component 21, collection component 1and transit component 21 may be compressed by application of inwardlydirected radial forces, and housed partially or wholly within cavity 36in head 32. While insertion rod 31 of plunger 3 is housed within theaxial conduit of assembled internal component 2, at least part of one orboth of collection component 1 and transit component 21 may in turn behoused within head 32 of plunger 3.

FIG. 12 shows an insertion sleeve 7 that houses collection component 1and transit component 21 either partially or completely duringinsertion. Insertion sleeve 7 comprises a hollow cylindrical orsubstantially cylindrical tube 71 open at both ends, having conduit 73connecting said both ends. The internal radius of conduit 73 is selectedto be larger than the radius of insertion rod 31.

The cross-sectional profile of insertion sleeve 7 may be small, andselected with a view to reduce trauma and foreign body sensation.

In an embodiment, tip 75 of one end of insertion sleeve 7 has a reducedcross-section in comparison to the cross-section of the rest ofinsertion sleeve 7, wherein tip 75 is dimensioned to provide aninterference fit with the inner walls of cylindrical cavity 36 in head32. The outer walls of insertion sleeve 7 may have a positivediscontinuity 72, for providing abutment surfaces on the outer walls ofthe insertion device. Said positive discontinuity 72 may comprise loops,flanges, lips, or any other form of protuberance that would provide asuitable abutment surface. Positive discontinuity 72 provides a physicaland visual indication of the depth to which insertion sleeve 7, and theinsertion device has been deployed within the rectum, and in some casesmay also act as a positive stop to prevent over-insertion by abuttingagainst portions of the anatomy adjacent the anal opening (the patient'sbuttocks). Said positive discontinuity 72 also provides leverage toanchor the insertion device to the patient's buttocks, therebyfacilitating one-handed operation of said insertion device.

In other embodiments of the insertion sleeve, the required physical orvisual indication of depth or insertion by way of visible orradio-opaque marker bands or a color coding to assist a care provider inpositioning collection component 1 within the rectum.

In the embodiment shown in FIG. 12, insertion sleeve 7 has a side slot74, which permits for deploying therewithin and withdrawing therefrom,collection component 1 and transit component 21.

FIG. 7 shows plunger rod assembly 3 with insertion sleeve 7 deployedthereon, wherein insertion rod 31 passes through conduit 73. In theembodiment shown, tip 75 of insertion sleeve 7 provides the necessaryinterference fit with cavity 36 within head 32, thereby ensuring thatinsertion sleeve 7 does not disengage from head 32 without a positiveapplication of force to disengage the two components.

FIG. 8 shows insertion device 4 in a fully assembled state. Assembledinternal component 2 houses insertion rod 31 of plunger 3 in the mannerillustrated in FIG. 6A, and in turn at least part of one or both ofcollection component 1 and transit component 2 are housed within cavity36 in head 32 of plunger 3.

In the embodiment shown in FIG. 8, at least part of one or both ofcollection component 1 and transit component 21 is housed within aconduit created by the plunger and insertion sleeve assembly of FIG. 7.Specifically, said conduit is a combined conduit comprising cavity 36within head 32 and conduit 73 within insertion sleeve 7. In anotherembodiment, the conduit for housing said assembled internal component 2comprises solely of conduit 73.

The pliant characteristics of collection component 1 permits for saidcomponent 1 to be compressed or collapsed and housed within the conduitprovided by the at least one of the plunger and insertion sleeveassembly of FIG. 7. Similarly, characteristics of transit component 21permit it to be compressed and housed within said conduit.

Both collection component 1 and transit component 21 are compressed orcollapsed around insertion rod 31 housed there within. Said plunger rod31 is accordingly also at least partially housed within the same conduitwithin which collection component 1 and transit component 21 are housed.Inner walls of the conduit provided by said at least one of the plungerand insertion sleeve assembly retain collection component 1 and transitcomponent 21 in a collapsed state and prevent them from expanding.

It would be apparent to a person of skill in the art that internaldiameter of conduit 73 within insertion sleeve 7 and of cavity 36 inhead 32 of plunger 3 require to be chosen based on the respectivedimensions of the components housed therewithin.

In the embodiment shown in FIG. 8, collection component 1 is housedwithin cavity 36 in head 32, and transit component 21 is partiallyhoused within conduit 73 in insertion sleeve 7. The remainder of transitcomponent 21 is permitted to trail outside insertion sleeve 7.

FIGS. 14 to 14C show the method of insertion and deployment of assembledinternal component 2 within the rectum using insertion device 4 of FIG.8.

In FIG. 14, a fully assembled insertion device 4 is ready fordeployment. Facing the insertion device is a profile of the rectalanatomy, comprising an anal opening 91, adjacent anatomy comprisingbuttocks 92, the rectum 93 and rectal walls 94 for rectum 93.

FIG. 14A shows insertion device 4 inserted into the rectum, with cappedend 34 entering anal opening 91 first. The device is inserted in rectum93 to an appropriate depth determined by the care provider. In thepreferred embodiment shown, the positive discontinuity 72 on insertionsleeve 7 provides an abutment surface that engages with adjacent anatomy92, thereby preventing further insertion of the device.

It would be apparent to the skilled person that location of the positivediscontinuity 72 on insertion sleeve 7 depends on the depth to which theinsertion device 4 is desired to be deployed within rectum 93.

FIG. 14B illustrates deployment of assembled internal component 2 withinrectum 93. Upon deployment of insertion device 4 to the desired depthwithin rectum 93, force directed upon base 33 of plunger 3 in thedirection of collection component 1 causes insertion rod 31 to move inan axial direction relative to insertion sleeve 7, thereby causing head32 to move in the same direction and simultaneously disengage frominsertion sleeve 7. Assembled internal component 2 however remains inthe same location relative to insertion sleeve 7, as a consequence offriction and interference between sheathing in assembled internalcomponent 2 and the inner walls of conduit 73. Since assembled internalcomponent 2 does not move, movement of plunger 3 causes displacement ofhead 32 relative to assembled internal component 2, including relativeto collection component 1 housed within cavity 36 in head 32. Sufficientdisplacement of head 32 relative to collection component 1 causes saidcomponent 1 to exit cavity 36 entirely.

In absence of the barrier to expansion provided by the inner walls ofcavity 36, collection component 1 expands and adheres to rectal walls 94of rectum 93 in the desired manner. Insertion sleeve 7 may thereafter beremoved by freeing such part of transit component 21 and insertion rod31 as remain housed therewithin. In the embodiment shown in FIG. 7, theremainder of transit component 21 may be removed via side slot 74. Onceinsertion sleeve 7 is removed, plunger 3 may be withdrawn by applyingforce in the proximal direction, to base 33. The withdrawing forcecauses plunger 3 to be withdrawn through the internal axial conduit ofassembled internal component 2, and may thus be removed entirely.

FIG. 14C shows collection component 1 and transit tube 21 deployed in adesired location within rectum 93, with the plunger 3 and insertionsleeve 7 of FIG. 8 having been withdrawn.

FIGS. 9, 10, 11, 13 and 13A show components for, and another embodimentof, a fully assembled device for insertion of assembled internalcomponent 2 into the rectum.

FIG. 9 shows a plunger 5 for the insertion device. Plunger 5 comprises arigid or semi-rigid insertion rod 52 having a head 51, a looped base 55and handle 54, which base 55 and handle 54 do not interfere with theanatomy, but provide significant assistance in safe insertion anddeployment of assembled internal component 2 within the rectum. Head 51may have a substantially spherical, cylindrical or conical tip, or a tipof any other shape that facilitates entry of plunger into rectum 93.

In a preferred embodiment, the leading portion of head 51 has a bluntrounded tip to facilitate insertion without trauma or discomfort. Loopedbase 55 and handle 54 provide a means for application of pressure toadvance plunger 5, or for gripping to withdraw said plunger 5. In anembodiment, the trailing portion 58 of head 51 has a reducedcross-section in comparison to the cross-section of the remainder ofhead 51. As discussed below said reduced cross-section serves to providean interference fit within conduit 84 of insertion sleeve 8.

Head 51 may be constructed from a variety of inert or biocompatiblematerials, including inter alia a soft, derma-tissue friendly material.Further, said head 51 may be shaped so as to facilitate smooth,non-traumatic insertion and removal. Head 51 may have one or morecoatings, a secondary substrate or substrates on its external surface,which improve lubricity while reducing tissue trauma and patientdiscomfort.

In a preferred embodiment, the cross-sectional profile of head 51 issmall, and selected with a view to reduce trauma and foreign bodysensation.

Handle 54 provides an abutment surface 56 for abutment against portionsof anatomy 92 adjacent to the anal opening 91. Said abutment surface 56may without limitation comprise shelves, flanges, lips, or any otherbarrier structure or protuberance that would provide an adequateabutment surface. Abutment surface 56 provides a physical and visualindication of the depth to which the insertion device has been deployedwithin rectum 93, and in some cases acts as a positive stop to preventover-insertion by abutting against portions of the anatomy 92 adjacentto the anal opening 91. In particular embodiments of plunger 5, therequired physical or visual indication of depth or insertion may beprovided by visible or radio-opaque marker bands or a color coding.

Abutment surface 56 also provides a locking mechanism 57, the objectiveand construction whereof are discussed below.

In an embodiment, insertion rod 52 has a positive discontinuity 53located between looped base 55 and head 51. Positive discontinuity 53provides an abutment surface on the insertion rod 52. Said positivediscontinuity 53 may comprise beads, loops, flanges, lips, or any otherprotuberance that would provide an adequate abutment surface. Thecross-sectional profile of positive discontinuity 53 is selected so asto permit free movement of insertion rod 52 within insertion sleeve 8.

As with the embodiment shown in FIG. 6A, during assembly of theinsertion device, insertion rod 52 of plunger 5 is housed within theinternal axial conduit of assembled internal component 2. Head 51 ofplunger 5 protrudes from opening 25 of assembled internal component 2.Base 55 protrudes from opening 24 of said assembled internal component2. Insertion rod 52 is housed within or substantially within the axialconduit of said assembled internal component 2.

FIGS. 13 and 13A show an insertion sleeve 8, for housing the assembledinternal component 2 either partially or completely during insertion.Insertion sleeve 8 comprises a hollow cylindrical or substantiallycylindrical tube 71 open at both ends, having conduit 84 connecting saidboth ends. The internal radius of conduit 73 is dimensioned to be largerthan the radius of insertion rod 52 for corresponding plunger 5.

At least one end of insertion sleeve 8 is provided with opposed flangesor handles 82 for manipulation of said insertion sleeve 8.

The inner diameter of conduit 84 is chosen to correspond to thecross-section of trailing portion 58 of head 51, such that trailingportion 58 provides an interference fit with the inner walls of conduit84, thereby providing for engagement between head 51 and insertionsleeve 8.

In a preferred embodiment, the cross-sectional profile of insertionsleeve 8 is small, and selected with a view to reduce trauma and foreignbody sensation.

In the embodiment shown in FIG. 13, insertion sleeve 8 has at least oneweakened wall portion 83. Said wall portion 83 is weakened in an axialdirection from one end of insertion sleeve 8 to the other. Applicationof simultaneous outwardly directed radial force to opposed flanges orhandles 82 causes for insertion sleeve 8 to tear along weakened wallportion 83, thereby creating a side slot for removal of any componenthoused within. In the embodiment shown in FIG. 13A, insertion sleeve 8has at least two weakened wall portions 83 on opposite sides of thesleeve circumference. Application of opposing forces on flanges orhandles 82 cause insertion sleeve 8 to tear along both weakened wallportions 83, thereby separating into two segments 81A and 81B andfacilitating removal of said insertion sleeve 8 from around anycomponent housed within.

Wall portions of insertion sleeve 8 may be weakened in a variety of waysthat would be apparent to a skilled person in view of the particularmaterials of construction for an insertion sleeve, including inter aliausing perforations, weak constructional material, pre-stressing ofmaterial, and prior separation of the insertion sleeve along the desiredweakened wall portion and subsequent reattachment using an appropriateadhesive. In another embodiment, frangible insertion sleeve 8 may beassembled and attached using inter alia one or more of adhesives, asnap-fit mechanism, shrink tubes or mechanical clips, staples, pins,removable bands.

The insertion sleeve may be made of a variety of materials includingmetals, alloys, thermoplastic polymers, natural or synthetic elastic orcompliant materials. The insertion sleeve may be coated or uncoated,both internally and externally. Coatings may be selected from the groupof hydrophilic, hydrophobic, friction enhancing, friction reducing,antimicrobial, anesthetic and anti-inflammatory coatings. The outsideand inside surfaces of the insertion sleeve may have the same ordifferent coatings, single or multiple coatings, and on single ormultiple locations to enhance desired behavior and properties.

FIG. 10 shows plunger 5 with insertion sleeve 8 deployed thereon,wherein insertion rod 52 passes through conduit 84. In the embodimentshown, trailing portion 58 of head 51 provides an interference fit withthe inner walls of conduit 84, thereby providing an interference fit andensuring that insertion sleeve 8 does not disengage from head 51 withouta positive application of force for disengagement. The embodiment inFIG. 10 also demonstrates the locking mechanism provided on plunger 5.Abutment surface 56 provides a lock 57 comprising any one of a flange,notch, lip, interference link, clutch, ratchet, or wrap and sealedcomponents. Said lock 57 engages with the proximal end of insertionsleeve 8, and prevents axial movement of insertion sleeve 8 relative toinsertion rod 52 in a proximal direction. Lock 57 ensures that insertionsleeve 8 is not axially displaced in a proximal direction duringinsertion in the rectum 93, as a result of resistance at the analopening 91 or from rectal walls 94 of rectum 93.

When insertion sleeve 8 is required to be withdrawn in a proximaldirection, lock 57 is first disengaged by moving it away from the lip ofinsertion sleeve 8. Construction of looped base 55 and handle 54 is suchas to confer sufficient flexibility to enable such movement. Insertionsleeve 8 may thereafter be withdrawn in a proximal direction.

FIG. 11 shows insertion device 4 in a fully assembled state. Assembledinternal component 2 houses insertion rod 52 of plunger 5 in the mannerdiscussed above.

In the embodiment shown in FIG. 11, collection component 1 and at leastpart of transit. component 2 are housed within conduit 84 in insertionsleeve 8.

The pliant characteristics of collection component 1 permits for saidcomponent 1 to be compressed or collapsed and housed within conduit 84.Similarly, the characteristics of transit component 21 permit for it tobe compressed and housed at least partially within said conduit 84. Itwould be noted that both collection component 1 and transit component 21are compressed or collapsed around insertion rod 52 housed therewithin.Said plunger rod 52 is accordingly also housed at least partially withinconduit 84. Collection component 1 is collapsed around plunger rod 52 ina manner such that proximal end 17 engages with the abutment surfaceprovided by positive discontinuity 53 on insertion rod 52.

The internal diameter of conduit 84 in insertion sleeve 8 may beselected based on the respective dimensions of the components intendedfor housing therewithin.

FIGS. 15 to 15D show the method of insertion and deployment of assembledinternal component 2 within rectum 93 using insertion device 6 of FIG.11.

In FIG. 15, fully assembled insertion device 6 is ready for deployment.Facing insertion device 6 is a profile of the rectal anatomy, comprisinganal opening 91, adjacent anatomy comprising buttocks 92, rectum 93 andrectal walls 94 of rectum 93.

FIG. 15A shows insertion device 6 inserted into rectum 93, with head 51entering anal opening 91 first. The insertion device 6 is inserted inrectum 93 to an appropriate depth determined by the care provider. Inthe embodiment shown, abutment surface 56 on plunger 5 engages withadjacent anatomy 92, thereby, preventing further insertion of the device6.

It would be apparent to the skilled person that location of abutmentsurface 56 on handle 54 depends on the depth to which insertion device 6is desired to be deployed within rectum 93.

FIG. 15B illustrates deployment of assembled internal component 2 withinrectum 93. Upon deployment of insertion device 6 to the desired depthwithin rectum 93, lock 57 is disengaged and insertion sleeve 8 iswithdrawn in an axially proximal direction, relative to plunger 5 andits components. Since plunger 5 remains stationary, withdrawal ofinsertion sleeve 8 causes said sleeve 8 to disengage from head 51.Assembled internal component 2 is prevented from simultaneously movingin the proximal direction by engagement between proximal end 17 andpositive discontinuity 53 on insertion rod 52.

As shown in FIG. 15C, neither assembled internal component 2 nor plunger5 is permitted to move in a proximal direction. Movement of insertionsleeve 8 in the proximal direction accordingly displaces collectioncomponent 1 relative to said sleeve 8. Sufficient displacement ofinsertion sleeve 8 relative to collection component 1 causes saidcomponent 1 to exit said sleeve 8 entirely.

In absence of the barrier to expansion earlier provided by the innerwalls of conduit 84 in insertion sleeve 8, collection component 1expands and adheres to rectal walls 94 of rectum 93 in the desiredmanner. Insertion sleeve 8 may then be removed entirely from rectum 93and thereafter from around assembled internal component 2 by fracturingor tearing along its weakened wall portions and removing it entirely.Once insertion sleeve 8 is removed, plunger 5 may be withdrawn byapplying a force in the proximal direction to handle 54 or looped base55. The withdrawing force causes plunger 5 to be withdrawn through theinternal axial conduit of assembled internal component 2, and thusremoved entirely.

FIG. 15D shows collection component 1 and transit tube 21 deployed in adesired location within rectum 93, with plunger 5 and insertion sleeve 8of FIG. 11 having been completely withdrawn.

In other embodiments of the invention, the withdrawal mechanism may bemechanically, hydraulically or pneumatically activated and assisted. Thewithdrawal mechanism may be self-activated based on internal or externaltriggers such as time based triggers or material properties (e.g.biodegradable polymers). The withdrawal mechanism may also have in-builtsecondary components, where such components aide the user in, visuallyor intuitively, determining length of the withdrawal stroke, securingthe insertion device at its optimal location within the rectum, ordetermining the position from which the insertion device may beoptimally withdrawn from rectum 93.

In a particular embodiment, the insertion assemblies 4 and 6 aredesigned for single use and may be constructed from eco-friendly andbiodegradable material.

1-31. (canceled)
 32. A collector for fecal discharge comprising: aself-expanding resilient collection component having an open proximalend, an open distal end and a lumen along the longitudinal axis of saidcomponent, said collection component lumen providing a passageconnecting said open proximal and distal ends, the collection componentcomprising a plurality of resilient arms interconnected to defineinterspaces therebetween and circumscribing the contour of thecollection component, adjacent arms of said component resiliently biasedaway from each other for exerting outwardly directed radial pressure forexpanding and anchoring said component to rectal walls upon deploymentwithin the rectum, said radial pressure being less than the pressureexerted by adjacent rectal walls during peristaltic contractions; ahousing sheath comprising a flexible and resilient material overlayingat least one of the inner or outer contour of said collection componentwhile maintaining the open proximal and distal ends of said componentand maintaining patency of the lumen connecting said open ends; and atransit component providing a conduit for fecal discharge to migratefrom the collection component to a receptacle therefor, said transitcomponent comprising a flexible substantially tubular sheath having afirst open end, a second end, and a lumen, said transit component lumenconnecting the first open end and the second end, wherein the first openend of the transit component engages with the proximal end of thecollection component.
 33. The collector for fecal discharge according toclaim 32, wherein arms of the collection component are pliant along thex, y and z axes.
 34. The collector for fecal discharge according toclaim 32, wherein arms of the collection component circumscribe any oneof a conical, frusto-conical or funnel-shaped contour, and the outersidewall connecting the proximal end and distal end of said collectioncomponent is at an outwardly directed angle of between 10° and 30° fromthe normal.
 35. The collector for fecal discharge according to claim 32,wherein the interconnected arms comprise a single continuous strand ofresilient wire material arranged to circumscribe the contour of thecollection component in an undulating configuration, and the free endsof said wire material are joined to complete said contour.
 36. Thecollector for fecal discharge according to claim 35, wherein saidcontinuous strand of resilient wire material is arranged in at least onetorsion loop on at least one of the vertices formed by the peaks andtroughs of the undulating wire material.
 37. The collector for fecaldischarge according to claim 32, wherein adjacent arms of the collectioncomponent are coupled with resilient connectors for biasing saidadjacent arms away from each other.
 38. The collector for fecaldischarge according to claim 37, wherein arms of the collectioncomponent are arranged in a series of crossed arm pairs arranged tocircumscribe the contour of said collection component, the crossed armswithin each pair coupled at their respective longitudinal midpoints by apivot pin, the free top and bottom ends of each crossed arm pair coupledrespectively to the adjacent free top and bottom ends of the laterallyadjacent crossed arm pairs by pivot pins, and the free top and bottomends of the first crossed arm pair and free top and bottom end of thelast crossed arm pair are coupled to complete said contour.
 39. Thecollector for fecal discharge according to claim 32, wherein thearrangement of arms circumscribing the contour of the collectioncomponent comprises a plurality of annular elements, the annularelements having substantially identical contours and being coaxiallyaligned along the longitudinal axis of the collection component, eachsaid annular element coupled to at least one adjacent annular element toachieve the contour of the collection component.
 40. The collector forfecal discharge according to claim 32, wherein the arrangement of armscircumscribing the contour of the collection component comprises aplurality of annular elements, the annular elements having substantiallyidentical contours and being coaxially aligned along the longitudinalaxis of the collection component, wherein the annular elements areretained in longitudinal alignment relative each other, by the housingsheath.
 41. The collector for fecal discharge according to claim 32,wherein at its widest point, the expanded collection component has anexternal diameter of between 20 mm and 60 mm.
 42. The collector forfecal discharge according to claim 32, wherein in its collapsed state,the collection component has an external diameter of between 6 mm and 21mm.
 43. The collector for fecal discharge according to claim 32, whereinthe expanded collection component has an internal diameter of between 20mm and 40 mm at the open proximal end, and an internal diameter ofbetween 20 mm and 60 mm at the open distal end.
 44. The collector forfecal discharge according to claim 32, wherein length of the collectioncomponent is between 10 mm and 50 mm.
 45. The collector for fecaldischarge according to claim 32, wherein the outwardly directed radialpressure exerted by the collection component is between 1 to 106 cm ofwater.
 46. The collector for fecal discharge according to claim 32,wherein the outwardly directed radial pressure exerted by the collectioncomponent is between 10 to 30 cm of water.
 47. The collector for fecaldischarge according to claim 32, wherein the collection component has atleast one filament attached thereto, the free ends of said at least onefilament trailing the proximal end of said collection component.
 48. Thecollector for fecal discharge according to claim 47, wherein the freeends of said at least one filament have differing slack.
 49. Thecollector for fecal discharge according to claim 47, wherein the atleast one filament is woven through the collection component in adrawstring arrangement.
 50. The collector for fecal discharge accordingto claim 47, wherein each trailing end of said at least one filament ishoused within a corresponding rigid or semi-rigid longitudinal conduitand thereafter connected to a handle, wherein each conduit permits freemovement of the filament residing therein along the direction of itslongitudinal axis, and one end of each conduit is located adjacent theproximal end of said collection component.
 51. The collector for fecaldischarge according to claim 32, wherein the second end of the transitcomponent is any one of an open end having a connector provided thereonfor engaging with the receptacle for fecal discharge, or a closed end,said closed end providing the receptacle for fecal discharge.